Enzolytics Offers Update on Virogentics and Sale Transaction, Clinical Trials Progress on European Medicine Agency (EMA) Permitting and Arican ITV-1 Project
COLLEGE STATION, TX / ACCESSWIRE / June 5, 2023 / Enzolytics, Inc. (OTC PINK:ENZC) (https://enzolytics.com/).
Enzolytics, Inc. (the “Company” or “ENZC”), a drug development biotech company, today provided updates regarding the sale of Virogentics, Inc. (“VIRO”) and Biogenysis, Inc. to Sagaliam Acquisition Corp (SAGA:NASDAQ GM) the special purpose acquisition company (“SPAC”) and details of the recently released comprehensive study prepared by the Bulgarian Academy of Science for use by Korporativ Klinik Drug Research and Development as part of the continued development of the program to meet EMA requirements for clinical trials; and status of the administration of the ITV-1 immunotherapy treatment under the supervision of Neuro Pharma Ltd – Rwanda.
To facilitate the transaction with Sagaliam Acquisition Corp (SAGA:NASDAQ GM) for purchasing the Company’s wholly owned subsidiaries, Biogenysis (“BGEN”) and Virogentics (“VIRO”), negotiations have been extended between BN Holdings Trust and the existing sponsor of SAGA to finalize their negotiations and complete certain regulatory filings. SAGA recently filed its December 31, 2022 annual report and is currently working to complete its March 31, 2023 quarterly filing with the Security Exchange Commission (“SEC”).
While there is no deadline for completion of the business combination agreement between ENZC and SAGA both parties will be working to complete the transaction as quickly as possible upon the completion of the regulatory filings and negotiations between the existing sponsor and BN Holdings Trust. The Company is not a party to the negotiations or filings but is being kept apprised of the progress being made.
A new comprehensive report prepared by the Bulgarian Academy of Sciences – Institute of Inorganic Chemistry and Phytotherapy was released last week for ITV-1, using two Bradford methods and spectrophotometric studies. The concentration of proteins in the final product was found to be in sufficient quantity to be able to bind and be active. The molecular masses of the peptides were determined. The amino acid sequence of 51 peptides in the ITV-1 samples have been identified. These and many other important pieces of information were obtained from this report along with schematics and diagrams. VIRO has engaged the German company Cooperative Clinical Research and Development (Korporativ Klinik Drug Research and Development) to prepare the Pharmacokinetic study on the porcine pepsin. This study is scheduled to begin on June 25, 2023. The production report and research dossier required for phase 3 clinical trials under the EMA guidelines are currently being prepared.
The final protocol for the administration of the ITV-1 immunotherapy treatment under the supervision of Neuro Pharma Ltd – Rwanda, to be dispensed to volunteers under a fast-track protocol at HEAL Africa Hospitals, GOMA, PRC and Panzi Hospital, Bukavu, DRC, is expected to be completed this week. The impact of the treatment on the HIV/AIDS virus present in the volunteers will be reported after the 17-week cycle is complete. The next step for VIRO is to acquire and fund the insurance premiums for the volunteers. VIRO expects ITV-1 to be dispensed under the trial in late July / early August 2023.
Harry Zhabilov, CSO of VIRO stated, “We are very fortunate to have successfully completed these steps in these projects and look forward to the continued success from the ENZC’s team efforts:.
Enzolytics, Inc. Overview
Enzolytics, Inc. is a drug development company committed to commercializing its proprietary proteins and monoclonal antibodies to treat debilitating infectious diseases. The Company is advancing multiple therapeutics targeting numerous infectious diseases. One patented and clinically tested compound, ITV-1 (Immune Therapeutic Vaccine-1), is a suspension of Inactivated Pepsin Fraction (IPF), covered by U.S. Patent Nos. 8,066,982 and 7,479,538. Studies have shown it to be effective in treating HIV/AIDS. ITV-1 has also been shown to modulate the immune system.
The Company has proprietary technology for producing fully human monoclonal antibodies (mAbs) against infectious diseases which is currently being employed to produce monoclonal antibody therapeutics for treating the CoronaVirus (SARS-CoV-2), HIV-1 and the Feline Leukemia virus. The Company has also identified conserved epitopes on and has plans to produce mAbs targeting many other viruses, including HIV-2, Influenza A and B, H1N1 influenza, Respiratory syncytial virus (RSV), Small-Pox, Ebola Virus, Tetanus, Diphtheria, HTLV-1/2, Rabies, Herpes zoster, Varicella zoster, Anthrax, Mason-Pfizer monkey virus (MPMV) and Visna virus (VISNA). The Company has also analyzed epitopes of animal viruses and plans to produce mAbs for treating these animal viruses.
Safe Harbor Statement: This news release contains forward-looking statements that involve risks and uncertainties associated with financial projections, budgets, milestone timelines, clinical development, regulatory approvals, and other risks described by Enzolytics, Inc. from time to time in its periodic reports filed with the SEC. ITV-1 is not approved by the U.S. Food and Drug Administration or by any comparable regulatory agencies elsewhere in the world.
While Enzolytics, Inc. believes that the forward-looking statements and underlying assumptions contained therein are reasonable, any of the assumptions could be inaccurate, including, but not limited to, the ability of Enzolytics to establish the efficacy of its therapeutics in the treatment of any disease or health condition, the development of studies and strategies leading to commercialization of its therapeutics in the United States, the obtaining of funding required to carry out the development plan, the completion of studies and tests on time or at all, and the successful outcome of such studies or tests. Therefore, there can be no assurance that the forward-looking statements included in this release will prove to be accurate.
Such forward-looking statements are based on current expectations. They involve inherent risks and uncertainties, including factors that could delay, divert or change any of the statements made, and cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. These forward-looking statements are made as of the date of this press release. The Company expressly disclaims any intention or obligation to update the forward-looking statements or update the reasons why actual results could differ from those projected in the forward-looking statements.
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SOURCE: Enzolytics, Inc.